Medicant Injection Device

ABSTRACT

A medicant injection device includes a compressible body, a tip, and an outer luer body. The compressible body has a proximal end, a distal end, and a plurality of bellows, and defines an inner cavity for holding a liquid medicant. The tip is positioned at the proximal end of the compressible body. The outer luer body includes internal threads, and is positioned over and engaged with the tip to form a first fitting therewith. The first fitting is configured to be connected with a second fitting. A medicant injection device includes a compressible body having first and second arms, a receptacle interconnected with the compressible body and defining an inner cavity, and a first fitting configured to engage a second fitting. The compressible body is configured to be compressed by forcing the distal end of the first and second arm toward each other.

RELATED APPLICATIONS

The present application claims the benefit of priority to U.S.Provisional Application No. 61/905,621, filed on Nov. 18, 2013, thedisclosure of which is incorporated herein by reference in its entirety.

BACKGROUND Field The present invention relates to a medicant injectiondevice and more specifically to a medicant injection device including acompressible container that includes luer features. Related Art

Prefilled syringes are a common type of injection device utilized in themedical field, and are often utilized for depositing a medicant dosageinto a patient. In this regard, prefilled saline flush syringes areoften utilized to ensure that a medicant dosage is fully deposited intoa patient, used to separate multiple subsequent injections of medicants,or to clear a catheter of blood after a blood draw. A saline flushsyringe is generally similar in type, quality, accuracy, andfunctionality as a syringe used for injection of medicants.

Sterile flush devices in the art generally come in two differentvarieties. A first type of current sterile flush device includesdisposable syringes that generally include a barrel, a piston, aplunger, and a luer cap. A second type of sterile flush device includesa three piece assembly that includes a barrel, a plunger, and a luercap. The plunger is designed to have a slight interference with thebarrel so that a piston is not required. Both first and second types ofsterile flush devices operate in a similar fashion and can comesterilized and prefilled with medicant. Additionally, each of the firstand second types of sterile flush devices requires the manufacture ofmultiple components that must interact with one another to operateeffectively, which increases the manufacturing costs of the devices.

The typical prefilled flush syringes often include extra capabilitiesthat are not required if the syringe is only being used to flush acatheter. These additional capabilities often require additionalcomponents that increase the overall manufacturing costs, making thesyringes more expensive. Further, because these additional capabilitiesare often not required, the additional expense incurred due to theadditional components is unnecessary. Accordingly, what is desired is aless costly injection device that can be provided with only thenecessary components, and thus with a reduced cost.

SUMMARY

The present invention relates to an alternative and less costly medicantinjection device and more specifically to a medicant injection deviceincluding a compressible container such as a fluid bag or a bottle withbellows, which includes luer and luer lock features.

In one aspect an injection device includes a bellowed body configured tohold a liquid medicant and a luer fitting. The body includes a proximalend and a distal end, with a hollow tip at the proximal end. The luerfitting is configured to be positioned over the tip and sealed with theproximal end of the body. The bellowed body is compressible, such that auser can compress the body by forcing the distal end towards theproximal end, or vice versa, in order to eject fluid medicant containedin the body from the tip to inject same into a patient. In one aspect,the body can include an enlarged locking bellows and the distal end ofthe body can include an annular locking protrusion. The annular lockingprotrusion is configured to engage and lock with the enlarged lockingbellows, while the enlarged locking bellows is configured to compressprior to compression of the remainder of the body. The engagement of theannular locking protrusion and the enlarged locking bellows functions toprime the injection device. In another aspect, the body includes afemale locking tab located at the proximal end, and a chamber and malelocking tab located at a distal end of the body and extending into thebody. The male locking tab is configured to engage the female lockingtab such that a user can engage the two during a final injection inorder to prevent reflux, spring-back, or reuse of the injection device.

In another aspect an injection device includes a bellowed bodyconfigured to hold a liquid medicant and a luer fitting. The bodyincludes a proximal end and a distal end, with a hollow tip and lockingshoulder at the proximal end. The luer fitting is configured to bepositioned over the tip and snap over the locking shoulder to secure theluer fitting to the body.

In another aspect an injection device includes a bag that iscompressible. The bag could be secured within a resiliently flexibleframe. The flexible frame includes a base, a luer/luer lock secured withthe base, and two arms extending, and diverging, from the base. The bagis configured to hold a liquid medicant. The flexible frame and bag arecompressible, such that a user can compress the flexible frame byforcing the first and second arms toward one another in order to ejectfluid medicant contained in the bag from the luer/luer lock to injectsame into a patient. In one aspect, the first arm can include a lockingridge, while the second arm can include a locking loop. The lockingridge and the locking loop are configured to engage one another suchthat a user can engage the two upon a completion of an injection inorder to prevent reflux, spring-back, or reuse of the injection device.

A medicant injection device includes a compressible body, a tip, and anouter luer body. The compressible body includes a plurality of bellows,a proximal end, and a distal end, and defines an inner cavity forholding a liquid medicant. The tip is positioned at the proximal end ofthe compressible body. The outer luer body is positioned over andengaged with the tip to form a first fitting that is configured to beconnected with a second fitting.

In another aspect a medicant injection device includes a compressiblebody, a receptacle connected to the compressible body, and a firstfitting. The compressible body includes first and second arms eachhaving a proximal end and a distal end, whereby the first and secondarms are connected at their respective proximal end forming a proximalbase. The receptacle defines an inner cavity for holding a liquidmedicant. The first fitting is positioned at the proximal base and isconfigured to engage a second fitting. The compressible body isconfigured to be compressed by forcing the distal end of the first armand the distal end of the second arm toward each other such that thefluid medicant contained in the inner cavity is ejected from the tipwhen the compressible body is compressed.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing features of the disclosure will be apparent from thefollowing Detailed Description, taken in connection with theaccompanying drawings, in which:

FIG. 1 is a front perspective view of a first embodiment of an injectiondevice of the present disclosure;

FIG. 2 is a sectional view of the injection device of FIG. 1;

FIG. 3a is a partial sectional view of a luer fitting and tip of theinjection device of FIG. 1;

FIG. 3b is a partial sectional view showing a non-uniform walled lockingbellow that inverts to generate a priming function;

FIG. 4a is a perspective view of a partially manufactured injectiondevice of FIG. 1;

FIG. 4b is a cross-sectional view of the injection device of FIG. 4 a;

FIG. 4c is a perspective view of a third step of manufacturing theinjection device of FIG. 4a further manufactured;

FIG. 4d is a perspective view of the injection device of FIG. 4a furthermanufactured;

FIG. 5 is a front perspective view of another injection device of thepresent disclosure;

FIG. 6 is a front perspective view of the injection device of FIG. 5with a removable tab removed;

FIG. 7 is a sectional view of the injection device of FIG. 6;

FIG. 8 is a rear perspective view of the injection device of FIG. 6;

FIG. 9a is a perspective view of a partially manufactured injectiondevice of FIG. 5;

FIG. 9b is a cross-sectional view of the injection device of FIG. 9 a;

FIG. 9c is a perspective view of the injection device of FIG. 9a furthermanufactured;

FIG. 10 is a perspective view of another aspect of an injection deviceof the present disclosure; and

FIG. 11 is a perspective view of a frame of the injection device of FIG.10.

DETAILED DESCRIPTION

FIGS. 1-4 d show a medicant injection device of the present disclosure.FIG. 1 is a front perspective view of a compressible injection device 10that is prefilled with a liquid medicant, e.g., saline, heparin, etc.The injection device 10 includes a bellowed body 12 having a proximalend 14, a distal end 16, and a plurality of bellows 18. The plurality ofbellows 18 on the body 12 form a bellows structure such that the body 12is compressible, e.g., the body 12 can be compressed so that theproximal end 14 and the distal end 16 are brought closer to one another.The injection device 10 also includes a luer fitting 20 formed by a tip42 at the end of the bellows 18 and an outer luer body 56 positionedabout the tip 42 and mounted to the injection device 10 at the proximalend 14. It is noted that one of ordinary skill in the art shouldunderstand that when reference is made to a “luer” or a “luer fitting”that this is not limited to only luer-type connections, but can be anydispensing geometry that is known or commonplace in the art.

FIG. 2 is a sectional view of the compressible injection device 10showing the components thereof in further detail. As illustrated in FIG.2, the body 12 defines an inner cavity 22 configured to be filled withand contain a liquid medicant. The distal end 16 of the body 12 includesa housing 24 that extends into the inner cavity 22. The housing 24defines a chamber 26. The housing chamber 26 is connected to the distalend 16 by an annular locking protrusion 28 that extends radially outwardto engage a locking bellows 30. The locking protrusion 28 and lockingbellows 30 are discussed in greater detail below. The chamber 26 of thehousing 24 is accessible by an aperture 32 located at a distal end ofthe housing 24 and formed in the distal end 16 of the body 12. Thehousing 24 can also include a male locking tab 34 extending from aproximal end of the housing 24. The male locking tab 34 includes a neck36 that connects with a head 38. The neck 36 and head 38 are generallycylindrical components, with the head 38 having a greater diameter thanthe neck 36, thus forming a locking lip 40. The male locking tab 34 isconfigured to lockingly engage a portion of the proximal end 14 of thebody 12, which is discussed in greater detail below. The housing 24 isseparate from the inner cavity 22 such that fluid in the inner cavity 22of the body 12 does not enter the housing 24. The chamber 26 of thehousing 24 is configured to receive a secondary accessory such as adisinfectant product, such as a SwabCap disinfecting cap sold byExcelsior Medical Corp. The secondary accessory can be retained in thechamber 26 by a friction fit, snap-fit, threaded connection, adhesive,ultrasonic weld, or spin weld, for example.

The body 12 further includes a tip 42 extending from the proximal end 14of the body 12. The tip 42 includes a female locking tab 44 extendingfrom the proximal end 14 of the body 12 and a luer nozzle 46, e.g., aluer seal surface, extending from the female locking tab 44. The tip 42is in communication with the inner cavity 22 of the body 12, such thatthe tip 42 defines an ejection chamber 48 and the nozzle 46 includes anaperture 50. The ejection chamber 48 and the aperture 50 allow fluid topass from the inner cavity 22, through the ejection chamber 48, and outof the aperture 50. The female locking tab 44 can also include anannular neck 52 that defines an internal locking shoulder 54 and anexternal shoulder 55. The female locking tab 44 is configured to receivethe male locking tab 34 such that the head 38 of the male locking tab 34can be inserted into the ejection chamber 48. Once in the ejectionchamber 48, the locking lip 40 of the male locking tab 34 engages thelocking shoulder 54 of the female locking tab 44, preventing the bellowsbody 12 from being “uncompressed” or “spring-back.” This is ananti-reflux feature that prohibits the injection device 10 from pullingfluids back out prior to removal, and prevents reuse of the device 10.Alternatively, the male locking tab 34 can engage the female locking tab44 with a friction fit, and the male end 34 can include a taperedgeometry.

FIG. 3a is a partial sectional view of the luer fitting 20 including theouter luer body 56 and the tip 42 of the injection device 10. Aremovable tab 58 is secured to the outer luer body 56 by a breakableinterface 60. The outer luer body 56 is configured to surround thefemale locking tab 44 and be sealed to the distal end 14 of the body 12.The female locking tab 44 can include a specific geometry, e.g., anoctagonal geometry, with the outer luer body 56 including a matinggeometry such that when the outer luer body 56 mates with the femalelocking tab 44 rotation of the outer luer body 56 is prevented. Theouter luer body 56 can include internal threading 62 for threadinglyengaging a mating luer access device. It should be understood by one ofordinary skill in the art that the internal threading 62 is not anecessity, but instead the tip 42 can be inserted into a female luerusing a luer slip configuration. The removable tab 58 includes first andsecond protrusions 64, 66. The first and second protrusions 64, 66 areconfigured to engage the luer nozzle 46 when the luer fitting 20 ispositioned over the tip 42. Specifically, the first protrusion 64 isconfigured to be inserted into and plug the luer nozzle 46, while thesecond protrusion 66 is annular in nature and configured to bepositioned about the luer nozzle 46. The luer fitting 20 is constructedsuch that a user can rotate the removable tab 58 to break the removabletab 58 off from the outer luer body 56 at the breakable interface 60,and then a user can compress the injection device 10 and expel anymedicant contained therein.

In operation, a user first engages the removable tab 58 to break theremovable tab 58 off from the luer fitting 20. The absence of theremovable tab 58 provides a visual indicator that the device 10 has beenopened, used, and/or that the sterile barrier has been breached.Accordingly, the removable tab 58 acts as a protective measure againstundesired reuse of the device 10. The user then primes the device 10 bybeginning to press the distal end 16 of the body 12 toward the proximateend 14. This initial compression causes the annular locking protrusion28 to engage the first bellow, namely locking bellows 30, allowing for aprime action to take place ensuring that no air is inside the device 10.The locking bellows 30 can include a single ridge, or multiple ridges,and the locking protrusion 28 can be sized to engage more than onelocking bellows 30. Further, one or more locking bellows 30 can beutilized to achieve the desired effect of a controlled dispense.Additionally, the locking bellows 30 can be sized larger or smaller,constructed of a thinner material, or constructed with other knowngeometries, so that it collapses easier or harder as desired.Alternatively, external geometry can be provided at the first bellows 18adjacent the locking bellows 30 that allows a user to grasp thereon toassist with the priming injection and ensure that only the primingbellows 30 is collapsed. The locking bellows 30 provide a mechanicaladvantage where the locking bellows 30 predictably collapse, and will beurged to collapse first and lock with the annular locking protrusion 28prior to any other bellows 18 collapsing. It is beneficial to have thelocking bellows 30 collapse easier than the other bellows 18 so that thelocking bellows 30 collapses without unnecessarily dispensing fluid fromthe device 10. Generally, the locking bellows 30 will have a lesservolume than the remainder of the bellows 18. After the locking bellows30 are engaged with the annular locking protrusion 28, the device 10 isprimed and stays primed until it is engaged to a luer access device.Once the device 10 is primed, a user connects the injection device 10 toa luer access device by engaging the luer fitting 20 with the lueraccess device, and the injection can begin. During the injection, theuser then presses the distal end 16 of the body 12 toward the proximateend 14, compressing the body 12. The bellows 18 also allow a user toexpand the body 12 during use in order to aspirate fluid and confirmpatency of the injection line prior to injection. Additionally, duringthe injection, the user can withdraw fluid by allowing the bellows ofthe body 12 to “spring back” to an expanded state where a vacuum iscreated and fluid is pulled back into the device 10. This motion can berepeated as needed until a final compression is made. During the finalcompression, the user can compress the body 12 such that the bellows ofthe body 12 are fully compressed, and the male locking tab 34 isadjacent the female locking tab 44. The user then applies an increasedforce to force the male locking tab 34 into the female locking tab 44,creating a “final lock.” The male locking tab 34 is retained in thefemale locking tab 44 through an engagement of the locking lip 40 of themale locking tab 34 engages the locking shoulder 54 of the femalelocking tab 44, preventing the bellows of the body 12 from being“uncompressed” or “spring-back.” This is an anti-reflux feature thatprohibits the injection device 10 from the unintentional withdraw offluid. Furthermore, the bellowed body 12 provides the user with tactilefeedback on how much force is required and how much pressure isgenerated during injection, as well as how much fluid has been injected.

The body 12 can also include exterior markings that provide a graduationmarking function, allowing a user to determine an amount of medicantthat has been ejected from the device 10. Additionally, the device 10can include markings related to the volume of the device 10, themedicant contained in the device 10, etc.

FIG. 3b is a partial sectional view showing a non-uniform walled lockingbellow 70 that inverts to generate a priming function, and which can beused in place of the locking below 30 of the injection device 10. Thelocking bellow 70 includes a non-uniform wall 72 that is capable ofdeflecting and inverting in on itself, creating a slight concavity 74.Specifically, as pressure is applied to the non-uniform wall 72 itdeflects until it reaches an inflection point where the wall 72 invertsitself inward, e.g., toward the proximal end 14 of the device 10, andlocks in this position, e.g., nested in on itself. This provides apriming function wherein ensuring that no air is inside the device 10.Further, the locking bellow 70 remains inverted, and locked, in theprimed position.

It should be understood by one of ordinary skill in the art that themale locking tab 34 and the female locking tab 44 are optionalcomponents, and the injection device 10 can be constructed without thesecomponents as a non-locking device.

It should also be understood by one of ordinary skill in the art thatthe housing 24 is not required and the injection device 10 can beprovided without the housing 24.

It should also be understood by one of ordinary skill in the art thatthe annular locking protrusion 28 and the locking bellows 30 are alsooption components, and the injection device 10 can be constructedwithout these components.

It should also be understood by one of ordinary skill in the art thatthe outer luer body 56 can be connected to the tip 42 by means otherthan a snap-fit connection, for example, friction fit, threadedconnection ,adhesive, ultrasonic weld, or spin weld, etc.

FIGS. 4a-4d illustrate the injection device 10 at stages duringmanufacturing. FIG. 4a illustrates the bellowed body 12 of the injectiondevice 10 first formed with a fill tip 68. The body 12 can be formedthrough blow molding, or other processes that are known in the art. FIG.4b is a cross-section of FIG. 4a , showing where the injection device 10is filled through the fill tip 68 and the tip 42, such that the innercavity 22 is filled with a liquid medicant. FIG. 4c illustrates anotherpartially manufactured device where the fill tip 68 is trimmed from thetip 42. FIG. 4d illustrates another partially manufactured device wherethe outer luer body 56, including luer threads, and the removable tab58, are pressed and trapped in place on the tip 42 to seal the tip 42.The luer fitting 20 can be injection molded. This allows the outer luerbody 56 to remain sterile during manufacture, and allows the outer luerbody 56 and removable tab 58 to be manufactured as a single part. Duringthe manufacturing process, a sterile barrier is provided for both theluer threads and the fluid path that leads to the inner cavity 22 by theapplication of the outer luer body 56, which creates a tortuous path atthe attachment of the outer luer body 56 to the tip 42.

FIGS. 5-9 c illustrate another injection device 100 incorporating analternative luer fitting for the injection device 10 of FIGS. 1-4 d.Elements illustrated in FIGS. 5-9 c that correspond substantially to theelements described above with reference to FIGS. 1-4 d have beendesignated with corresponding reference numerals. The injection device100 shown in FIGS. 5-9 c operates and is constructed consistent with theforegoing description of the injection device 10 of FIGS. 1-4 d, unlessstated otherwise. Particularly, FIG. 5 is a perspective view of theinjection device 100 that includes a bellowed body 112 having aplurality of bellows 118 and defining an inner cavity 122. The body 112has a proximal end 114 and a distal end 116. The injection device 100includes an alternative luer fitting 170 having an alternative outerluer body 172 secured to the tip 142. The luer fitting 170 can includethe outer luer body 172, and a removable tab 174 is secured to the outerluer body 172 by a breakable interface 176. The luer fitting 170 isconstructed such that a user can rotate the removable tab 174 to breakthe removable tab 174 off from the outer luer body 172 at the breakableinterface 176, thus allowing a user to compress the injection device 100and expel any medicant contained therein. FIG. 6 is a front perspectiveview of the injection device 100 with the removable tab 174 removed fromthe outer luer body 172.

FIG. 7 is a sectional view of the injection device 100 showing the luerfitting 170 in greater detail. Similar to the injection device 10 ofFIGS. 1-4 d, the distal end 116 of the body 112 includes a housing 124that extends into the inner cavity 122, and includes a male locking tab134. The housing 124 defines a chamber 126 that is configured to receivea secondary device 178 such as a cleaning device, such as a SwabCapdisinfecting cap sold by Excelsior Medical Corp (see also FIG. 8 whichis a rear perspective view of the injection device 100 having a cleaningdevice 178 within the chamber 126). The secondary accessory 178 can beretained in the chamber 26 by a friction fit, snap-fit, threadedconnection, adhesive, ultrasonic weld, or spin weld, for example. Theproximal end 114 includes a tip 142 extending therefrom that can includea female locking tab 144 and a nozzle 146. The female locking tab 144includes an annular neck 152 that defines an internal locking shoulder154 and an external shoulder 155. The outer luer body 172 of the luerfitting 170 includes an internal annular ridge 180 that is configured toengage the external shoulder 155 of the female locking tab 144.Specifically, the outer luer body 172 is configured to be positionedover the tip 142, and pressed toward the distal end 116 of the injectiondevice 100 until the internal annular ridge 180 snaps over the femalelocking tab 144 and engages the external shoulder 155. It should also beunderstood by one of ordinary skill in the art that the outer luer body172 can be connected to the tip 142 by means other than a snap-fitconnection, for example, friction fit, threaded connection ,adhesive,ultrasonic weld, or spin weld, etc. Accordingly, the annular neck 152defines a notch that the internal annular ridge 180 of the outer luerbody 172 engages. The outer luer body 172 can include internal threading182 for threadingly engaging a mating luer access device.

The injection device 100 of FIGS. 5-9 c operates in substantialconformity with the injection device 10 of FIGS. 1-4 d described indetail above.

It should be understood by one of ordinary skill in the art that themale locking tab 134 and the female locking tab 144 are optionalcomponents, and the injection device 100 can be constructed withoutthese components as a non-locking device.

It should also be understood by one of ordinary skill in the art thatthe housing 124 is not required and the injection device 100 can beprovided without the housing 124.

It should also be understood by one of ordinary skill in the art thatthe annular locking protrusion 128 and the locking bellows 130 are alsooptional components, and the injection device 100 can be constructedwithout these components.

FIGS. 9a-9c illustrate the injection device 100 at stages duringmanufacturing. FIG. 9a illustrates a bellowed body 112 of the injectiondevice 100 first formed with a fill tip 168. The body 112 can be formedthrough blow molding, injection molding, or other processes that areknown in the art. FIG. 9b illustrates a second manufacturing step wherethe injection device 100 is filled through the fill tip 168 and the tip142, such that the inner cavity 122 is filled with a liquid medicant.FIG. 9c illustrates that the outer luer body 172 is snapped onto the tip142. The fill tip 162 is then compressed and heat sealed, and optionallytrimed, to form the removable tab 174, thus sealing the inner cavity122. The outer luer body 172, the tip 142, the fill tip 168, and theremovable tab 174 can be injection molded. Accordingly, compressing thefill tip 168 to form the removable tab 174 allows for the knownmanufacturing processes to be leveraged. During the manufacturingprocess the fluid path that leads to the inner cavity 122 remainssterile. The threaded area of the outer luer body 172, the interior ofthe outer luer body 172, and the tip 142 can be kept sterile throughadditional packaging.

FIGS. 10 and 11 illustrate another aspect of the medicant injectiondevice of the present disclosure. FIG. 10 is a perspective view of aninjection device 200. The injection device 200 includes a collapsibleframe 202, a luer/luer-lock fitting 204, and a receptacle 206, such as acontainer or bag. The receptacle 206 can be a laminate film foil bagconstructed of, for example, polyethylene terephthalate (PET),polyethylene (PE), foil, linear low density polyethylene (LLDPE), whichare common for fluid storage or other suitable structures. Thereceptacle 206 can also be made of a malleable material such as thickfoil that does not “spring-back” and remains in a collapsed state aftercompression. The receptacle 206 can be heat sealed to the frame 202 orattached by other appropriate means, e.g., adhesive, ultrasonic welding,spin welding, over molding, etc. The receptacle 206 is configured tocontain a liquid medicant. The luer/luer-lock fitting 204 can be moldedas a single piece with the collapsible frame 202, or can be molded as aseparate piece and attached to the collapsible frame 202. Alternatively,the receptacle 206 can be attached to the fitting 204 directly and thecollapsible frame 202 not utilized.

FIG. 11 is a perspective view of the collapsible frame 202 that canprovide support for the receptacle 206. The collapsible frame 202includes a proximal base 208, and first and second arms 210, 212extending distally from the proximal base 208. The first and second arms210, 212 can be configured as plate members. The first arm 210 includesa proximal end 214 and a distal end 216, the proximal end 214 beingattached to the proximal base 208. The second arm 212 includes aproximal end 218 and a distal end 220, the proximal end 218 beingattached to the proximal base 208. Thus, the first and second arms 210,212 are configured wherein their respective proximal end, 214, 218 areattached with the proximal base 208, and their distal ends 216, 220diverge. The distal ends 216, 220 of the first and second arms 210, 212can be moved together by squeezing them together to pivot the arms aboutthe proximal base 208 to cause the liquid medicant contained in thereceptacle 206 to be forced out of the luer/luer-lock fitting 204 andinjected into a patient. Additionally, the distal ends 216, 220 of thefirst and second arms 210, 212 can be pulled apart, providing anaspiration function so that the connected line can be checked forpatency prior to injection. The collapsible frame 202 could bespring-loaded to allow a user to repeatedly inject and withdrawal asneeded. Further, a ratcheting mechanism can be included between thefirst and second arms 210, 212 to provide a priming function and allow ametered or controlled injection. The frame 202 could be adhered to thereceptacle 206 by, for example, bonding or glue, to provide structuralsupport and increased fluid control. Additionally, the first arm 210 caninclude a locking ridge 222 at the distal end 216, while the second arm212 can include a locking loop 224 at the distal end 220. The lockingridge 222 and the locking loop 224 are configured to have matinggeometries such that the locking loop 224 can engage and lock with thelocking ridge 222 when the medicant is fully injected to prevent thefirst and second arms 210, 212 from being “uncompressed” or“springing-back.” This is an anti-reflux feature that prohibits theinjection device 200 from the unintentional withdraw of fluid, as wellas preventing reuse of the injection device. The luer/luer-lock fitting204 can include a check valve incorporated therein to prevent fluid fromflowing back into the injection device 200, e.g., reflux, and allowsfluid to only flow out of the injection device 200. The injection devicecan also include a luer cap to seal the luer/luer-lock fitting 204 andretain the sterility of the luer/luer-lock fitting 204. The collapsibleframe 202 can be injection molded. It should be understood by one ofordinary skill in the art that the collapsible frame 202 can be providedon the inside or the outside of the receptacle 206.

In operation, a user connects the injection device 200 to a luer accessdevice by engaging the luer/luer-lock fitting 204 with the luer accessdevice, such as threaded engagement, and the injection can proceed.During the injection, the user presses the distal end 216 of the firstarm 210 and the distal end 220 of the second arm 212 toward each other,compressing the receptacle 206. Additionally, during the injection, theuser can withdraw fluid by allowing the first and second arms 210, 212to “spring back” to an expanded state where a vacuum is created andfluid is pulled back into the device 200. This motion can be repeated asneeded until a final compression is made. During the final compression,the user compresses the first and second arms 210, 212 such that thereceptacle 206 is fully compressed, and the locking ridge 222 isadjacent the locking loop 224. The user then applies an increased forceto force the locking ridge 222 into the locking loop 224, creating a“final lock.” The locking ridge 222 is retained in the locking loop 224through an engagement of the two, preventing the compressible frame 202from being “uncompressed” or “spring-back.” This is an anti-refluxfeature that prohibits the injection device 200 from the unintentionalwithdraw of fluid. Furthermore, the construction of the injection device200 provides the user with tactile feedback on how much force isrequired and how much pressure is generated during injection, as well ashow much fluid has been injected.

The injection devices described herein can be steam sterilized or maymake use of various high volume sterilization methods such as gammasterilization or ethylene oxide (EtO) sterilization. Additionally, theinjection devices described herein can be sized to accommodate commonsized syringe volumes, e.g., 3 milliliters, 5 milliliters, 10milliliters, etc. Further, the injection devices described herein aresized to create a mechanical leverage. A target nominal value of sevenpounds per square inch to deliver the injection can be targeted, with ahigh value of twenty-four pounds per square inch. The injection devicesare generally constructed to include a mechanical advantage requiringthe lowest pressure necessary. The injection devices are constructedwithout non-essential functionality to reduce cost. Still further, theinjection devices described herein are sterile and disposable, providesa barrier to maintain sterility, and conform to all InternationalOrganization for Standardization (ISO) luer lock standards such as ISO594.

It should be understood by one of ordinary skill in the art that thelocking ridge 222 and the locking loop 224 are optional components, andthe injection device 200 can be constructed without these componentssuch that it is a non-locking device.

Additionally, each of the devices 10, 100, 200 can include a check valveand/or a two-way pressure activated valve that only allows fluid flowwhen a certain pressure is achieved.

It is to be understood that the foregoing description is not intended tolimit the spirit or scope of the disclosure. It will be understood thatthe aspects of the disclosure described herein are merely exemplary andthat a person skilled in the art may make many variations andmodification without departing from the spirit and scope of thedisclosure. All such variations and modifications, including thosediscussed above, are intended to be included within the scope of thedisclosure.

1.-26. (canceled)
 27. A medicant injection device, comprising: acompressible body including a first arm and a second arm, wherein thefirst and second arms are connected at a base region of the compressiblebody and are spaced apart at a compressible region opposite the baseregion, the compressible body further including a first fittingintegrally formed with the first and second arms at the base region; anda receptacle interconnected with the compressible body and defining aninner cavity for holding a liquid medicant; wherein at least one of thefirst arm and the second arm is at least partially disposed within thereceptacle, and wherein the compressible body is configured to becompressed by forcing the first and second arms, proximate thecompressible region, toward each other such that the liquid medicantcontained in the receptacle is ejected from the first fitting when thecompressible body is compressed.